FDA Medical Device Recalls (openFDA)
Tecan US, Inc.: Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
- Recall number
- Z-2663-2016
- Recalling firm
- Tecan US, Inc.
- Product
- Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
- Status
- Terminated
- Initiated
- 2016-07-25
- Posted
- 2016-08-25
- Terminated
- 2017-01-23
- Reason
- The batteries have the potential to overheating, melt or char.
- Root cause
- Nonconforming Material/Component
- Action
- Tecan contacted all customers by Safety Announcement, via certified mail starting July 25, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Because affected batteries pose a fire and burn hazard, it is extremely important that customers check whether their battery is affected. Customers were advised to go immediately to the HP Battery Recall website at: http://www.HP.com/go/batteryprogram2016 to check if their battery is affected by this recall. Customers were also advised to complete and return the Customer Response Form at QA@tecan.com or fax it to 919-287-2961. Customers with questions should contact HP at 1-888-202-4320 or Tecan Technical Service's Helpdesk at 800-832-2687, option 1.
- Quantity
- 27 units
- Distribution
- Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
- Lot, serial or model codes
- Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940: PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJQ
- Firm FEI
- 1037985
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28